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Gait in Children With Down Syndrome While Wearing Orthoses

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01598350
Recruitment Status : Completed
First Posted : May 15, 2012
Results First Posted : December 30, 2013
Last Update Posted : December 30, 2013
Information provided by (Responsible Party):
Julia Looper, University of Puget Sound

Brief Summary:

On average, Down syndrome (DS) occurs once in every 700 live births and results in life-long disability and increased risk for comorbidities.1 Individuals with DS are also susceptible to secondary physical impairments and limitations as a result of complications associated with joint hypermobility, hypotonicity, and increased ligamentous laxity. Secondary impairments such as pes planus (flat feet), weakened muscles, bony abnormalities and arthritis may lead to painful joints and feet. Additionally, children with DS often manifest deviations in gait as a result of physical limitations imposed by orthopedic and muscular deficiencies that may lead to decreased postural stability. These secondary losses in function, which exacerbate disabilities, may be preventable with the use of appropriate early interventions aimed at correcting abnormal joint alignment. Research exploring effective physical therapy interventions for adults and children with DS is currently very limited. However, the use of orthotic devices to support lax ligaments and hypotonic muscles, which are common manifestations of DS, is one accepted method of intervention for children within this population. Orthoses are variable in structure and the degree of support provided to the foot and ankle also differ between foot orthoses (FOs) and supramalleolar orthoses (SMOs). Previous studies have supported the effectiveness of orthoses on improving ankle and foot alignment, as well as gait parameters. However, disagreement currently exists concerning which type of orthotic device is most beneficial for the population of children with DS. Children with DS express variable degrees of joint laxity and hypotonicity, as well as differences in the severity of specific alignment abnormalities such as excessive pronation or calcaneal eversion.6 Current literature is insufficient for explaining differences in the benefits provided by FOs and SMOs and the specific indications for their use in children with DS is unclear.

Study Aims This study will demonstrate the differences in structural outcomes provided by FOs and SMOs and develop specific criterion for matching individuals of differing orthopedic impairments with the most beneficial orthotic device.

Condition or disease Intervention/treatment Phase
Down Syndrome Device: Supramalleolar Orthoses (Cascade) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Using Anthropometric Measurements to Predict Orthotic Influence on Gait Parameters in Children With Down Syndrome
Study Start Date : January 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Down Syndrome

Arm Intervention/treatment
Experimental: Orthotic
Orthotic Use
Device: Supramalleolar Orthoses (Cascade)
Walk wearing supramalleolar orthoses - three trial
Other Name: Cascade - leap frog

Primary Outcome Measures :
  1. Step Width [ Time Frame: 60 minutes ]

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Participants must be able to walk independently or with an assistive device, for 50 feet at one time, and have at least six months of walking experience. Participants must also be able to follow simple verbal instructions.

Exclusion Criteria:

  • Exclusion criteria include a history of uncorrected visual and inner ear impairments, and lower extremity orthopedic surgical corrections.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01598350

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United States, Washington
University of Puget Sound
Tacoma, Washington, United States, 98406
Sponsors and Collaborators
University of Puget Sound
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Responsible Party: Julia Looper, Assistant Professor, University of Puget Sound Identifier: NCT01598350    
Other Study ID Numbers: 0910-003
First Posted: May 15, 2012    Key Record Dates
Results First Posted: December 30, 2013
Last Update Posted: December 30, 2013
Last Verified: November 2013
Keywords provided by Julia Looper, University of Puget Sound:
Down syndrome
Additional relevant MeSH terms:
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Down Syndrome
Pathologic Processes
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn